Innovations in Regenerative Medicine

Bio-Tissue is a leader in the use of cryopreserved amniotic membranes.

By Thomas G. Daniells

With ocular surface disease (OSD) becoming more prevalent, the focus on diagnosis and treatment has become paramount. If left untreated, OSD can impair a patient’s vision and damage the cornea, which can have long-term consequences including scarring or blindness. We know that treating OSD-related inflammation is key; however, multifactorial symptoms must also be simultaneously addressed. Common treatments such as steroids and nonsteroidal antiinflammatory drugs can reduce inflammation, but they can also delay corneal epithelial healing.


Founded to address an unmet need for a better surgical and therapeutic approach to treating ocular surface conditions, Bio-Tissue has pioneered the use of cryopreserved amniotic membrane for healing and repair. Initial research began in the 1980s, led by Scheffer C.G. Tseng, MD, PhD, who believed the solution was to utilize the natural antiscarring, antiinflammatory, and antiangiogenic properties of human amniotic membrane tissue to encourage higher quality wound healing.

Dr. Tseng introduced the use of amniotic membrane for ocular surface reconstruction with a novel method of processing and preservation called the CryoTek method. The National Institutes of Health has supported our research for more than 25 years, and there are now more than 300 peer-reviewed scientific publications and clinical studies supporting the technology.

Today, Dr. Tseng serves as the company’s chief scientific officer and, together with our CEO Amy Tseng, MBA, leads our mission of researching and delivering innovative products for regenerative healing. Eye care professionals around the world have used our tissue solutions more than 200,000 times to help heal patients’ eyes and improve their quality of life.

Figure. Rose bengal staining showing exposure keratitis (L). After treatment with Prokera: note the cornea with no staining (R).


Bio-Tissue’s proprietary CryoTek cryopreservation method maintains the structural integrity and key biologics of the amniotic membrane. These include the heavy-chain hyaluronic acid/pentraxin 3 (HC-HA/PTX 3) biologic signaling matrix that is necessary for controlling inflammation and scarring and expediting quality healing. The HC-HA/PTX 3 matrix halts the adult immune response, suppresses the formation of matrix metalloproteinases, giant cells, and T cells; HC-HA/PTX 3 also promotes stem cell proliferation and regeneration.1-4

A recent paper presented at the ASCRS Meeting that won best of session demonstrated through the placement of Prokera in patients with moderate to severe DED, the recovery of corneal surface health can accelerate and can last for at least 3 months.5 The study also demonstrated corneal nerve regeneration and return of corneal sensitivity. Overall the DEWS score improved from 2.9 ±0.3 at baseline to 1.1 ± 0.3 at 1-month and 1.0 at 3 months in the treatment group.


Bio-Tissue’s CryoTek amniotic membrane products include AmnioGraft, a biologic ocular transplantation graft; UCGuard, a biologic glaucoma shunt tube graft; and Prokera biologic corneal bandages, the only therapeutic devices cleared by the FDA that reduce inflammation and scarring and simultaneously promote healing of the ocular surface (Figures).

We also developed Cliradex, a preservative-free lid, lash, and face cleanser. Cliradex includes the isolated-terpineol molecule, the most important component of tea tree oil, which has been shown clinically to safely and effectively clean patients’ eyelids and lashes and to eradicate Demodex mites.6


Bio-Tissue’s products benefit a wide array of indications, and treating early in the disease spectrum is an important part of optimal patient care. The company’s groundbreaking research in the study of regenerative medicine continues, with a focus on future cellular and tissue-based drug and biologic products derived from amniotic membrane, umbilical cord, and organic materials. Developments on the horizon are at the forefront of innovation in regenerative medicine, and they hold promise to leverage the proprietary scientific discoveries found in birth tissue and specifically target therapeutic areas involving the ocular surface and the retina. n

1. He H, Li W, Chen YT, et al. Suppression of activation and induction of apoptosis in RAW264.7 cells by amniotic membrane extract. Invest Ophthalmol Vis Sci. 2008;49(10):4468-4475.

2. He H, Tan Y, Duffort S, et al. In vivo downregulation of innate and adaptive immune responses in corneal allograft rejection by HC-HA/PTX3 complex purified from amniotic membrane. Invest Ophthalmol Vis Sci. 2014;55(3):1647-1656.

3. Li W, He H, Chen YT, et al. Reversal of myofibroblasts by amniotic membrane stromal extract. J Cell Physiol. 2008;215(3):657-664.

4. Cooke M, Tan EK, Mandrycky C, et al. Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/chorion tissue. J Wound Care. 2014;23(10):465-474,476.

5. John T. Corneal nerve regeneration after self-retained cryopreserved amniotic membrane in dry eye disease. Paper prestented at: ASCRS/ASOA Annual Symposium & Congress; May 9, 2016; New Orleans, LA.

6. Tighe S. Gao YY, Tseng SC. Terpinen-4-ol is the most active ingredient of tea tree oil to kill Demodex mites. Transl Vis Sci Technol. 2013;2(7):2.

Thomas G. Daniells
• Chief commercial officer, Bio-Tissue; (888) 296-8858